Binimetinib - Generic Drug Details

What are the generic drug sources for binimetinib and what is the scope of patent protection?

Binimetinib is the generic ingredient in one branded drug marketed by Array Biopharma Inc and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Binimetinib has two hundred and thirty-one patent family members in fifty-five countries.

One supplier is listed for this compound. There are two tentative approvals for this compound.

Summary for binimetinib

International Patents:	231
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	92
Clinical Trials:	94
Patent Applications:	3,165
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for binimetinib
What excipients (inactive ingredients) are in binimetinib?	binimetinib excipients list
DailyMed Link:	binimetinib at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for binimetinib

Constraining patent/regulatory exclusivity:

9,562,016

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for binimetinib

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Merck Sharpe & Dohme LLC	Phase 2
National Cancer Center, Japan	Phase 2
National Cancer Institute, France	Phase 3

See all binimetinib clinical trials

Generic filers with tentative approvals for BINIMETINIB

Applicant	Application No.	Strength	Dosage Form
		15MG	TABLET
		15MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Anatomical Therapeutic Chemical (ATC) Classes for binimetinib

L01EE	Mitogen-activated protein kinase (MEK) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for BINIMETINIB

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MEKTOVI	Tablets	binimetinib	15 mg	210498	3	2022-06-27

US Patents and Regulatory Information for binimetinib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018		RX	Yes	Yes	9,598,376
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018		RX	Yes	Yes	9,562,016		Y	Y
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018		RX	Yes	Yes	9,850,229
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018		RX	Yes	Yes	9,314,464

Expired US Patents for binimetinib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018	8,178,693
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018	8,513,293
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018	8,193,229

EU/EMA Drug Approvals for binimetinib

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pierre Fabre Medicament	Mektovi	binimetinib	EMEA/H/C/004579 Binimetinib in combination with encorafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.	Authorised	no	no	no	2018-09-20

International Patents for binimetinib

Country	Patent Number	Title	Estimated Expiration
Cyprus	1109727
Montenegro	01860
Japan	5475888
Brazil	112012004453

Supplementary Protection Certificates for binimetinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2727918	300975	Netherlands		PRODUCT NAME: COMBINATIE VAN BINIMETINIB EN ENCORAFENIB, BEIDE IN ALLE VORMEN ZOALS BESCHERMD DOOR HET BASISOCTROOI; REGISTRATION NO/DATE: EU/1/18/1314 20180924
2470526	CA 2019 00012	Denmark		PRODUCT NAME: ENCORAFENIB I ALLE FORMER BESKYTTET AF GRUNDPATENTET; REG. NO/DATE: EU/1/18/1314 20180924
1482932	C 2019 008	Romania		PRODUCT NAME: BINIMETINIB; NATIONAL AUTHORISATION NUMBER: EU/1/18/1315; DATE OF NATIONAL AUTHORISATION: 20180920; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1315; DATE OF FIRST AUTHORISATION IN EEA: 20180920
2470526	300973	Netherlands		PRODUCT NAME: ENCORAFENIB; REGISTRATION NO/DATE: EU/1/18/1314 20180924

Market Dynamics and Financial Trajectory for Binimetinib

Market Overview

Binimetinib, a MEK inhibitor, is a targeted treatment primarily used for advanced melanoma and other cancers. The market for binimetinib is poised for significant growth, driven by several key factors.

Growth Drivers

• Increasing Incidence of Cancer: The rising incidence of melanoma and solid tumors globally is a major driver for the demand of targeted therapies like binimetinib[1].
• Advances in Precision Medicine: The tailoring of treatments based on tumor genetics has increased the use of binimetinib, as it targets specific cellular pathways, making it more efficient and tolerable for patients[1].
• Therapeutic Efficacy and Side Effects: Patients prefer binimetinib due to its therapeutic efficacy and manageable side effects, contributing to its growing demand[1].
• Ongoing Research and Development: Continuous research and development efforts are expanding the applications of binimetinib, further boosting its market growth[1].

Regional Market Dynamics

• North America: This region currently dominates the binimetinib market, with a significant share driven by advanced healthcare infrastructure and high adoption rates of targeted therapies[1].
• Europe: Europe is the second-largest region, with substantial demand fueled by rising cancer incidence, supportive government initiatives, and a well-established pharmaceutical industry[1].
• Asia Pacific: This region is expected to be the fastest-growing segment during the forecast period, driven by a large and expanding cancer population, particularly in China and India, along with increasing healthcare expenditure and infrastructure[1].

Key Market Players

The binimetinib market is dominated by a few major companies:

• Pfizer: Following its acquisition of Array BioPharma in 2019 for $11.4 billion, Pfizer has become a key player in the market. Pfizer's financial reports indicate significant investments in oncology products, including binimetinib[5].
• Alembic Pharma: Another major player, Alembic Pharma is involved in the production and commercialization of binimetinib, particularly in the API market[4].
• Other Players: Companies like MSN Laboratories, Hetero Drugs, and BOC Sciences also play crucial roles in the binimetinib API market[4].

Financial Trajectory

Revenue and Growth

• The binimetinib market is projected to grow at a compound annual growth rate (CAGR) of XX% from 2024 to 2034, reaching a significant market value by the end of the forecast period[1].
• The market was valued at USD XX Million in 2024 and is expected to increase substantially over the next decade[1].

Pricing Trends and Average Selling Prices

• The pricing of binimetinib is influenced by various factors, including production costs, regulatory approvals, and market competition. The average selling prices (ASPs) are expected to stabilize as the market matures and more players enter the scene[1].

Recent Financial Highlights

• Pfizer's financial reports show that while the company experienced a decline in revenues from COVID-19 related products, there was a 5% operational growth in revenues excluding contributions from Comirnaty and Paxlovid. This growth was partly driven by recently acquired products, including those in the oncology segment[2].

Development and Commercialization Costs

• The development and commercialization of binimetinib involve significant costs. Array BioPharma and Pierre Fabre have agreed to split these costs on a 60:40 basis, with initial funding committed for new clinical trials in colorectal cancer and melanoma[3].

Impact of Collaborations and Acquisitions

• The collaboration between Array BioPharma and Pierre Fabre has been instrumental in the global development and commercialization of binimetinib. Array retains exclusive commercialization rights in the U.S., Canada, Japan, Korea, and Israel, while Pierre Fabre has rights in other countries[3].
• Pfizer's acquisition of Array BioPharma has further strengthened its position in the oncology market, providing the financial and operational resources to drive the growth of binimetinib[5].

Regulatory Approvals and Clinical Trials

• Regulatory approvals play a crucial role in the market growth of binimetinib. For instance, the U.S. FDA's acceptance of supplemental New Drug Applications (sNDAs) for Braftovi (encorafenib) and Mektovi (binimetinib) in April 2023 is a significant milestone[2].
• Ongoing and planned clinical trials, such as the Phase 3 trials for melanoma and ovarian cancer, are critical for expanding the therapeutic applications of binimetinib[3].

Market Challenges and Limitations

• Despite the growth drivers, the binimetinib market faces challenges such as high development costs, regulatory hurdles, and competition from other targeted therapies[1].
• The market is also subject to the risks associated with clinical trial outcomes and the ability of companies to meet development and commercialization milestones[3].

Key Takeaways

• The binimetinib market is driven by increasing cancer incidence, advances in precision medicine, and ongoing research.
• North America and Europe are significant markets, with the Asia Pacific region expected to grow rapidly.
• Pfizer and Alembic Pharma are key players, with other companies contributing to the API market.
• The market is expected to grow at a significant CAGR, with substantial revenue growth projected.
• Collaborations and acquisitions, such as Pfizer's acquisition of Array BioPharma, are crucial for market growth.

FAQs

What is binimetinib used for?

Binimetinib is primarily used to treat advanced melanoma and certain other cancers by inhibiting the MEK protein, which prevents the growth and spread of cancer cells.

Which companies are major players in the binimetinib market?

The major players include Pfizer, Alembic Pharma, MSN Laboratories, Hetero Drugs, and BOC Sciences.

What are the key drivers of the binimetinib market?

The key drivers include the increasing incidence of cancer, advances in precision medicine, therapeutic efficacy, and ongoing research and development.

How is the Asia Pacific region contributing to the binimetinib market?

The Asia Pacific region is expected to be the fastest-growing segment due to a large and expanding cancer population, increasing healthcare expenditure, and improving healthcare infrastructure.

What is the impact of regulatory approvals on the binimetinib market?

Regulatory approvals, such as those from the U.S. FDA, are crucial for the market growth of binimetinib, as they validate the safety and efficacy of the drug and allow for broader commercialization.

Sources

1. We Market Research - Binimetinib Market Research Report 2024-2034
2. Pfizer - Pfizer Reports First-Quarter 2023 Results
3. PR Newswire - Array BioPharma And Pierre Fabre Announce Development And Commercialization Collaboration For Two Novel Oncology Products
4. Valuates Reports - Global Binimetinib API Market Insights, Forecast to 2029
5. Pfizer - Pfizer to Acquire Array BioPharma

Last updated: 2024-12-16